Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Trial Status: Active
To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.
- Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
- Patients for whom surgical or radiological treatment of lesions is contraindicated
- At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Anticipated life expectancy >12 weeks
- All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.
- Prior treatment with an oncolytic therapy
- Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
- Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
- Untreated brain metastasis(es) that may be considered active.
- Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
City of Hope Comprehensive Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
Contact: Wanxing Chai-Ho
Stanford Cancer Institute Palo Alto
University of California San Diego
University of Colorado Hospital
University of Miami Miller School of Medicine-Sylvester Cancer Center
Moffitt Cancer Center
Emory University Hospital / Winship Cancer Institute
University of Iowa / Holden Comprehensive Cancer Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Laura and Isaac Perlmutter Cancer Center at NYU Langone
UNC Lineberger Comprehensive Cancer Center
Case Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
M D Anderson Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase II
Trial Type Treatment
- Primary ID RPL-002-18
- Secondary IDs NCI-2019-06779
- Clinicaltrials.gov ID NCT04050436